A typical previously-known filling cannula or probe used for aseptic or so called “sterile” filling comprises a hollow filling tube including an outlet port in fluid communication between the hollow interior of the filling tube and ambient atmosphere. A previously-known filling cannula or probe, for example, includes a hollow stainless steel shaft, a bulbous tip fixedly secured to the distal end of the shaft, and diametrically opposed outlet ports proximal to the tip and in fluid communication between the interior of the shaft and the ambient atmosphere. One drawback encountered with previously-known filling cannulas and needles is that the interior of the cannula or probe, and any fluid contained therein or passing therethrough, can be exposed to the ambient atmosphere via the open fluid ports. In connection with known filling machines, regulatory agencies require control of the cannula or probe environment in order to protect against exposure of a sterile product to the environment and the resulting contamination of the product that might occur. However, typical controlled environments, such as a class 100 (ISO-5) controlled environment, are not truly sterile. Although the likelihood of contamination in such reduced-contaminant environments may be relatively low, just one colony of contaminants can develop into a container full of germs over its shelf-life. This risk is exacerbated when filling traditional open containers that are thereafter sealed in an assembly machine. No such previously-known assembly machine, such as, for example, a typical machine closing 40,000 containers per hour, can fully prevent entrance of viables and non-viables into the containers. On the other hand, if the cannula or probe is used to dispense a contaminated fluid, or a fluid that might be harmful if it is exposed to or comes into contact with an operator, the open ports can allow such fluid to contaminate its ambient atmosphere or potentially harm the operator that contacts the cannula or probe or is in the vicinity thereof.
A typical fluid connector includes a male connector that is received within a female connector to place the two connectors in fluid communication with each other. The male and female connectors may be threadedly engaged, snap fit, or otherwise releasably connected to each other to allow for interconnection and disconnection. Each connector is coupled in fluid communication with a respective fluid passageway, such as a tube or fluid chamber, in order to place the fluid passageways in fluid communication with each other and allow the passage of fluids through the connected elements.
Such fluid connectors typically do not prevent the contamination of fluids passing through them, unless the connector is sterile handled and connected in a relatively low challenging environment (even then, the connectors must be sealingly connected to each other to prevent ingress of contaminants, which means the connection cannot be disengaged). For example, prior to interconnection of the male and female connectors, the fluid-contacting surfaces thereof can be exposed to the ambient atmosphere and contaminated through contact with airborne germs and/or by contact with contaminated surfaces. One approach to preventing such contamination is to wipe the fluid-contacting surfaces of the male and female connectors with an alcohol wipe or other disinfectant prior to interconnection. One drawback of this approach is that the fluid-contacting surfaces may become contaminated after the wipe is applied to the male and female connectors. Another drawback of this approach is that it can be time consuming and considered a nuisance, and therefore unreliable in practice. There is no previously-known connector capable connection within a contaminated liquid or contaminated aerosol chamber that prevents the contamination of fluids passing therethrough.
Accordingly, aseptic or sterile fluids can be subjected to contamination when passed through such previously-known connectors. If used in a hospital or other medical facility, such as to transfer sterile drugs or other fluids intended for intravenous injection, for example, any such contamination can lead to bloodstream infections, e.g., catheter related blood stream infections (CRBSI). CRBSI represent about 15% of nosocomial infections per year. According to the Center for Disease Control (CDC), approximately 200,000 cases CRBSI are reported in the United States per year and cost the country about $35 billion in treatment costs. CRBSI leads to about 30,000 deaths per year in United States hospitals. In food processing applications, on the other hand, it may be necessary to connect fluid conduits, for example, in order to transfer sterile or aseptic fluids from one passageway to another. If the fluids are contaminated upon passage through a fluid connector, this can lead to contamination of previously-sterile food products, and if such contaminated products are ingested, they can cause infections and/or illnesses. In industrial applications, it may be necessary to prevent a toxic fluid passing through a connector from contaminating the ambient atmosphere, an operator handling the connector, and/or other surfaces that might be located external to the connector. If the fluid-contacting surfaces of the connector are exposed to human contact, or surfaces that come into human contact, for example, this can lead to possible injury and/or illnesses. For example, operators exposed to the transfer of liquids such as immune suppressants or hormones, can suffer from pulmonary absorption of such products.